Regulation of Patient Management Software‪.‬

1 Introduction Faced with rising service costs and aging populations, governments and health care organizations in North America and Europe have little choice but to improve the efficiency and efficacy of medical care delivery. While culprits abound, research has shown that many inefficiencies and quality problems arise from a lack of access to relevant information. Common examples include unnecessary duplication of laboratory work, cancellation of scheduled treatments on account of missing data, and prescription of unnecessary (or even harmful) drugs. As a result of these concerns, governments and health organizations are investing in the development and acquisition of information and communications technology (ICT), including decision support systems, electronic medical record (EMR) software, and telemedicine. While these initiatives promise benefits for health care delivery, the use of software systems in the health care domain raises new concerns about safety, effectiveness, privacy, and security. Of these issues, safety and effectiveness are perhaps the most important. Research studies have estimated that medical errors result in up to 98,000 deaths each year in the United States, with costs approximated to $30 billion. (1) Unfortunately, experience has shown that software systems have the potential to generate life-threatening errors. (2)